Active substanceQuetiapineQuetiapine
Similar drugsTo uncover
  • Victorel
    pills inwards 
    AKTAVIS GROUP, AO     Iceland
  • Hedonin
    pills inwards 
    VALEANT, LLC     Russia
  • Quentiax®
    pills inwards 
    KRKA-RUS, LLC     Russia
  • Quentiaks® SR
    pills inwards 
  • Quetiapine
    pills inwards 
    VERTEKS, AO     Russia
  • Quetiapine
    pills inwards 
  • Quetiapine
    pills inwards 
    ATOLL, LLC     Russia
  • Quetiapin Canon
    pills inwards 
  • Quetiapin Canon Prolong
    pills inwards 
  • Quetiapin San
    pills inwards 
  • Quetiapine Stade
    pills inwards 
  • Quetiapine Vial
    pills inwards 
    VIAL, LLC     Russia
  • Quetiapine-SZ
    pills inwards 
    NORTH STAR, CJSC     Russia
  • Cvetitex
    pills inwards 
  • Ketiap
    pills inwards 
  • Ketilept®
    pills inwards 
  • Koumental
    pills inwards 
    Sandoz d.     Slovenia
  • Lakvel
    pills inwards 
  • Nantaride®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Servitor®
    pills inwards 
  • Seroquel®
    pills inwards 
    AstraZeneca UK Ltd     United Kingdom
  • Seroquel® Prolong
    pills inwards 
    AstraZeneca UK Ltd     United Kingdom
  • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet, film-coated, contains:

    Dosage of 25 mg:

    active substance: quetiapine hemifumarate 28.78 mg, equivalent to 25 mg quetiapine;

    Excipients: hypromellose - 1.40 mg, calcium hydrogen phosphate dihydrate - 3.50 mg, lactose monohydrate - 7.00 mg, corn starch - 13.82 mg, sodium carboxymethyl starch - 3.50 mg, magnesium stearate - 0.89 mg, microcrystalline cellulose - 7.94 mg, talc - 1.75 mg, silicon dioxide colloid - 1.42 mg;

    tablet shell: opaque pink 02B34304 - 2.00 mg (iron dye red oxide (E172) - 0.031 mg, iron dye oxide yellow (E172) - 0.028 mg, hypromellose-2910 (E464) 1.25 mg, titanium dioxide (E171) - 0 , 56 mg, macrogol 400 - 0.125 mg, dye sunset yellow sunset (E110) - 0.003 mg).

    Dosage100 mg:

    active substance: quetiapine hemifumarate 115.13 mg, equivalent to 100 mg quetiapine;

    Excipients: hypromellose 5.60 mg, calcium hydrogen phosphate dihydrate 14.00 mg, lactose monohydrate 28.00 mg, corn starch 55.27 mg, sodium carboxymethyl starch 14.00 mg, magnesium stearate 3.56 mg microcrystalline cellulose - 31.75 mg, talc - 7.00 mg, silicon dioxide colloid - 5.69 mg;

    tablet shelland: Opapray yellow 02B32696 - 8.00 mg (iron oxide yellow oxide (El72) 0.25 mg, hypromellose-2910 (E464) 5.0 mg, titanium dioxide (E171) 2.25 mg, macrogol 400 0.50 mg).

    Dosage 200 mg:

    active substance: quetiapine hemifumarate 230.27 mg, equivalent to 200 mg quetiapine;

    Excipients: hypromellose - 11,20 mg, calcium hydrogen phosphate dihydrate 28.00 mg, lactose monohydrate 56.00 mg, corn starch 110.54 mg, sodium carboxymethyl starch 28.00 mg, magnesium stearate 7.11 mg, cellulose microcrystalline 63.50 mg , talcum - 14.00 mg, silicon colloidal dioxide - 11.38 mg;

    tablet shell: opadray white 20A28735 - 12.00 mg (giprolose (E463) - 3.59 mg, hypromellose-2910 (E464) - 3.59 mg, titanium dioxide (E171) - 3.51 mg, talc - 1.31 mg).

    Description:

    Tablets 25 mg: Two-convex round tablets covered with a film coat of orange-pink color.

    Tablets 100 mg: Biconvex round tablets covered with a film coating of yellow color with a risk on one side.

    Tablets 200 mg: Biconvex round tablets covered with a film coating of white color with a risk on one side.

    Pharmacotherapeutic group:antipsychotic agent (antipsychotic)
    ATX: & nbsp

    N.05.A.H.04   Quetiapine

    Pharmacodynamics:Quetiapine is an atypical antipsychotic. Quetiapine and its active metabolite N-dealkyl quetiapine interact with neurotransmitter receptors of the brain. Quetiapine and N-dealkyl quetiapine show a high affinity for serotonin receptors of the type 5NT1 and dopamine type receptors D1 and D2 head the brain. Higher selectivity for serotonin 5HT receptors2, than to dopamine receptors of the type D2, causes the main clinical antipsychotic properties of quetiapine and a low incidence of extrapyramidal side effects. Besides, N-dealkyl quetiapine shows a high affinity for the carrier of norepinephrine. Quetiapine and N-dealkyl quetiapine have a high affinity for histamine and α1-adrenergic receptors and a lower affinity for α2-adrenoceptors and serotonin receptors such as 5HT1 quetiapine does not show a significant affinity for the cholinergic muscarinic and benzodiazepine receptors. In standard tests quetiapine has antipsychotic activity. The specific contribution of the metabolite N-dealkyl quetiapine in the pharmacological activity of quetiapine is not established.

    The results of the study of extrapyramidal symptoms (EPS) in animals revealed that quetiapine causes a weak catalepsy in doses effectively blocking dopamine D2 receptors. Quetiapine causes a selective decrease in the activity of mesolimbic A10-dophaminergic neurons in comparison with A9-nigrostriate neurons involved in motor function.

    Clinical studies (quetiapine 75-750 mg / day) showed no difference between quetiapine and placebo in the incidence of extrapyramidal symptoms and the concomitant use of anticholinergic drugs. Quetiapine does not cause a prolonged increase in the concentration of prolactin in the blood plasma.

    Quetiapine is effective in treating both positive and negative symptoms of schizophrenia. Long-term support of clinical improvement in those patients who had a positive effect at the very beginning of treatment.

    The duration of action of quetiapine on 5HT receptors2 and D2 is less than 12 hours after taking the drug.

    Pharmacokinetics:

    When administered orally quetiapine well absorbed from the gastrointestinal tract and actively metabolized in the liver. The intake of food does not significantly affect the bioavailability of quetiapine.Approximately 83% of quetiapine binds to plasma proteins.

    The equilibrium molar concentration of the active metabolite N-Dealkyl quetiapine is 35% of the equilibrium molar concentration of quetiapine. The half-life of quetiapine and N-Dealkyl quetiapine is about 7 and 12 hours, respectively. The pharmacokinetics of quetiapine and N-Dealkyl quetiapine is linear, there are no differences in pharmacokinetic parameters in men and women. Determined that CYP3A4 is the key isoenzyme of quetiapine metabolism, mediated by cytochrome P450. N-dealkyl quetiapine is formed with the participation of isoenzyme CYP3 A4.

    The average clearance of quetiapine in elderly patients is 30-50% less than in patients aged 18 to 65 years.

    The average plasma clearance of quetiapine is reduced by approximately 25% in patients with severe renal insufficiency (creatinine clearance less than 30 ml / min / 1.73 m2), but individual clearance rates are within the values ​​corresponding to healthy volunteers. In patients with impaired liver function (eg, compensated alcoholic cirrhosis), the mean plasma clearance of quetiapine is reduced by approximately 25%. Because the quetiapine is intensively metabolized in the liver, in patients with hepatic insufficiency it is possible to increase the plasma concentration of quetiapine, which requires a dose adjustment.

    On average, less than 5% of the molar dose of the fraction of free quetiapine and N-dezalkil quetiapine plasma are excreted in the urine. Approximately 73% of quetiapine is excreted by the kidneys and 21% by the intestine. Less than 5% of quetiapine is not metabolized and is excreted unchanged by the kidneys or through the intestines.

    In a study of the pharmacokinetics of quetiapine in varying doses, the use of quetiapine prior to the administration of ketoconazole or concomitantly with ketoconazole resulted in an increase, on average, in the maximum concentration (CmOh) and the area under the curve "concentration-time" (AUC) quetiapine 235% and 522%, respectively, and to reduce the clearance of quetiapine, on average, by 84%. Quetiapine half-life increased, but the mean time to reach maximum concentration (tmax) did not change.

    Quetiapine and some of its metabolites, including N-dealkyl quetiapine, have a weak inhibitory activity against cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6 and 4a, but only at concentrations 10-50 times higher than the concentrations observed at the usual effective dose of 300-450 mg / day.

    Based on the results in vitro, it should not be expected that simultaneous use of quetiapine with other drugs will lead to a clinically pronounced inhibition of the metabolism of other medicaments mediated by cytochrome P450.

    Indications:

    For the treatment of schizophrenia.

    For the treatment of manic episodes in the structure of bipolar disorder.

    The drug is not indicated for the prevention of manic episodes in bipolar disorder.

    Contraindications:

    Hypersensitivity to any of the components of the drug. Joint use with cytochrome P450 inhibitors (antifungal agents of the azole group, erythromycin, clarithromycin, nefazodone, protease inhibitors); deficiency of lactase, glucose-galactose malabsorption, lactose intolerance; psychoses in elderly patients with dementia; children's age till 18 years; lactation period; pregnancy.

    Carefully:

    In patients with cardiovascular and cerebrovascular diseases or other conditions,predisposing to arterial hypotension; elderly age; liver failure; convulsive fits in the anamnesis.

    Pregnancy and lactation:

    Safety and effectiveness of the drug in pregnancy is not established, so the drug is prescribed only in the case when the benefits for the mother exceed the risk to the fetus. If the drug is used during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Inside, regardless of food intake.

    Adults

    Treatment of schizophrenia

    Servitor® is prescribed 2 times a day. The daily dose for the first 4 days of therapy is: the 1st day - 50 mg, the second day - 100 mg, the third day - 200 mg, the 4th day - 300 mg. Starting from the 4th day, the dose should be selected up to a clinically effective dose, which usually ranges from 300 to 450 mg / day. Depending on the clinical effect and individual patient tolerance, the dose may vary from 150 to 750 mg / day. The maximum recommended daily dose is 750 mg.

    Treatment of manic episodes in the structure of bipolar disorder

    Servitor® is used as a monotherapy or as an adjuvant therapy for mood stabilization.

    Servitor® is prescribed 2 times a day.The daily dose for the first 4 days of therapy is: the 1st day - 100 mg, the second day - 200 mg, the third day - 300 mg, the 4th day - 400 mg. In the future, 6The day of therapy, the daily dose of the drug can be increased to 800 mg. An increase in the daily dose should not exceed 200 mg per day.

    Depending on the clinical effect and individual patient tolerance, the dose may vary from 200 to 800 mg / day. Usually the effective dose is from 400 to 800 mg / day. The maximum recommended daily dose is 800 mg.

    Elderly

    In elderly patients, the initial dose of quetiapine is 25 mg / day. The dose should be increased daily by 25-50 mg until an effective dose is obtained, which is likely to be less than in young patients.

    Patients with renal and hepatic insufficiency

    In patients with renal or hepatic insufficiency, it is recommended to start quetiapine therapy with 25 mg / day. It is recommended to increase the dose daily by 25-50 mg until the effective dose is reached.

    Side effects:

    The most common side effects when taking quetiapine are: drowsiness, dizziness, dry mouth, mild asthenia, constipation, tachycardia, orthostatic hypotension and dyspepsia.

    The use of quetiapine, as well as other antipsychotics, may be accompanied by weight gain, fainting, malignant neuroleptic syndrome, leukopenia, neutropenia, and peripheral edema.

    The frequency of adverse reactions is given in the following gradation: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10 000, <1/1000); very rarely (<1/10 000), including cases whose frequency is not known.

    From the central nervous system: very often - drowsiness2, dizziness4, headache; often - dysarthria, unusual and nightmarish dreams, fainting4, extrapyramidal symptoms; infrequently - convulsions1, restless legs syndrome; very rarely - tardive dyskinesia6.

    From the side of the cardiovascular system: often - orthostatic hypotension, tachycardia4.

    From the gastrointestinal tract: very often - dry mouth; often - constipation, indigestion; infrequently - dysphagia; rarely - jaundice6; very rarely - hepatitis6.

    From the respiratory system: often - rhinitis.

    On the part of the blood system: often - leukopenia1; infrequently - eosinophilia; frequency not known - neutropenia1 .

    From the immune system: infrequently - hypersensitivity reaction; very rarely - anaphylactic reactions6.

    From the skin: very rarely - angioedema6, Stevens-Johnson syndrome6.

    Metabolic disorders: very rarely - diabetes mellitus1,5,6.

    Changes in laboratory and instrumental indicators: very often - an increase in the concentration of triglycerides, total cholesterol (mainly low-density lipoprotein cholesterol); often - weight gain, increased activity of hepatic transaminases (aspartate aminotransferase (ACT) and alanine aminotransferase (ALT))3, decrease in the number of neutrophils, hyperglycemia7; infrequently - increased activity of creatine phosphokinase, not associated with malignant neuroleptic syndrome, thrombocytopenia.

    Other: very often - withdrawal syndrome; often - asthenia, peripheral edema, blurred vision; rarely - priapism, malignant neuroleptic syndrome.

    1. See section "Special instructions".

    2. Drowsiness usually occurs within the first 2 weeks after initiation of therapy and is usually resolved against the backdrop of continued use of quetiapine.

    3. Perhaps an asymptomatic increase in activity ACT, ALT and γ-glutamyltranspeptidase (GGT) in the blood serum, as a rule, reversible against the background of continued use of quetiapine.

    4. Like other antipsychotics quetiapine often causes orthostatic hypotension, which is accompanied by dizziness, tachycardia and in some cases - fainting, especially at the beginning of therapy.

    5. Very rare cases of decompensation of diabetes mellitus have been noted.

    6. The frequency of this side effect was estimated based on the results of post-marketing surveillance.

    7. An increase in fasting blood glucose> 126 mg / dl (> 7.0 mmol / L) or post-prandial glucose> 200 mg / dl (> 11,1 mmol / l), at least for a single application.

    Interval lengthening QT, ventricular arrhythmia, sudden death, cardiac arrest and bidirectional ventricular tachycardia are considered side effects of neuroleptics.

    Quetiapine therapy is associated with a small dose-dependent decrease in the concentration of thyroid hormones, in particular, total thyroxine (T4) and free T4. Maximum reduction in total and free T4 registered at the 2 nd and 4 th week of quetiapine therapy without further decrease in the concentration of hormones during long-term treatment. Thereafter, there were no signs of clinically significant changes in the concentration of thyroid-stimulating hormone.In almost all cases, the concentration of total and free T4 returned to the baseline after quetiapine therapy was discontinued regardless of the duration of treatment. A slight decrease in total triiodothyronine (T3) and the reverse T3 It was noted only when high doses were used. The level of thyroxine-binding globulin (TSH) remained unchanged, and there was no increase in the thyroid-stimulating hormone (TSH) level.

    Overdose:

    Data on quetiapine overdose are limited. Cases of quetiapine administration in a dose exceeding 20 g, without fatal consequences and with full recovery. Very rarely reported cases of quetiapine overdose, leading to death or coma.

    In patients with severe cardiovascular disease in history, the risk of side effects in overdose may increase.

    Symptoms: The symptoms noted during overdose were mainly due to the enhancement of known pharmacological effects of the drug, such as drowsiness and excessive sedation, tachycardia and lowering blood pressure.

    Treatment: there are no specific antidotes to quetiapine.In cases of serious intoxication, it is necessary to consider the possibility of symptomatic therapy, and it is recommended to carry out activities aimed at maintaining the function of respiration, cardiovascular system, ensuring adequate oxygenation and ventilation of the lungs. Gastric lavage (after intubation, if the patient is unconscious) and the appointment of activated charcoal and laxatives can promote the removal of unabsorbed quetiapine, but the effectiveness of these measures has not been studied.

    Close medical surveillance should continue until the patient's condition improves.

    Interaction:

    With the simultaneous administration of drugs that have a strong inhibitory effect on the isoenzyme CYP3A4 (such as the azole antifungal agents and macrolide antibiotics), the concentration of quetiapine in the plasma may increase.

    In a study of the pharmacokinetics of quetiapine in a different dosage with the administration of quetiapine before or simultaneously with ketoconazole, an increase in the maximum concentration (Cmax) and the area under the curve "concentration-time" (AUC) quetiapine 5-8 times, as well as to reduce the clearance of quetiapine.Quetiapine half-life increased, but the mean time to reach maximum concentration (tmOh) did not change. In such cases, lower doses of quetiapine should be used. Special attention should be paid to elderly and weakened patients. It is necessary to individually evaluate the relationship between risk and benefit for each patient. Therefore, co-administration of quetiapine and cytochrome inhibitors CYP3A4 is contraindicated. It is also not recommended to take quetiapine together with grapefruit juice. Simultaneous administration of quetiapine with drugs inducing the enzyme system of the liver, such as carbamazepine, it is possible to reduce the concentration of the drug in the plasma, which may require an increase in the dose of quetiapine, depending on the clinical effect. In a study of the pharmacokinetics of quetiapine in varying doses, when administered prior to or concomitantly with carbamazepine (a hepatic enzyme inducer), the quetiapine clearance significantly increased. This increase in quetiapine clearance reduced AUC an average of 13% compared with the use of quetiapine without carbamazepine.

    The simultaneous administration of quetiapine to another inducer of microsomal liver enzymes, phenytoin, also led to an increase in the clearance of quetiapine. With the simultaneous administration of quetiapine and phenytoin (or other inducers of hepatic enzymes, such as barbiturates, rifampicin) may require an increase in the dose of quetiapine. It may also be necessary to reduce the dose of quetiapine when the phenytoin or carbamazepine or other inducer of the liver enzyme system is canceled or replaced with a drug that does not induce microsomal liver enzymes (for example, valproic acid).

    The pharmacokinetics of lithium preparations does not change with the simultaneous administration of quetiapine.

    There were no clinically significant changes in the pharmacokinetics of valproic acid and quetiapine in the joint administration of valproate semetriya and quetiapine.

    Quetiapine did not induce the induction of hepatic enzyme systems involved in the metabolism of phenazone.

    The pharmacokinetics of quetiapine does not change significantly when administered concomitantly with antipsychotic drugs - risperidone or haloperidol.However, simultaneous administration of quetiapine and thioridazine led to increased clearance of quetiapine.

    The pharmacokinetics of quetiapine does not change significantly with the simultaneous use of cimetidine, a cytochrome P450 inhibitor.

    The pharmacokinetics of quetiapine did not change significantly with the simultaneous administration of an antidepressant imipramine (an inhibitor of the isoenzyme CYP2D6) or fluoxetine (inhibitor of isoenzymes CYP3A4 and CYP2D6).

    Pharmacokinetic studies on the interaction of quetiapine with drugs used in cardiovascular disease have not been conducted. Caution should be exercised in the combined use of quetiapine and drugs that can cause electrolyte imbalance and lengthening of the interval QTc.

    Caution should be exercised in the combined use of quetiapine with other drugs that affect the central nervous system, as well as with alcohol, as this may increase the risk of side effects of quetiapine.

    Special instructions:Drowsiness

    During therapy with quetiapine, drowsiness and related symptoms, for example sedation (see Sect.section "Side effect"). In clinical studies involving patients with depression in the structure of bipolar disorder, sleepiness tended to develop during the first three days of therapy. The severity of this side effect was mostly mild or moderate. With the development of severe drowsiness, patients with depression in the structure of bipolar disorder may need more frequent visits to the doctor during 2 weeks from the onset of drowsiness or to a decrease in the severity of symptoms. In some cases quetiapine therapy may be discontinued.

    Patients with cardiovascular diseases

    Caution should be exercised when assigning quetiapine to patients with cardiovascular and cerebrovascular diseases, and other conditions predisposing to hypotension. Against the background of quetiapine therapy, orthostatic hypotension may occur, especially in the initial period of dose selection (in elderly patients it is observed more often than in young patients). If orthostatic hypotension occurs, a dose reduction or slower titration may be required.

    Interval lengthening QT

    There was no correlation between taking quetiapine and increasingQT interval. However, the lengthening of the interval QT was noted during an overdose of the drug (see section "Overdose"). Caution should be exercised in appointing quetiapine to patients with cardiovascular disease and the previously noted lengthening of the interval QT, as well as with simultaneous use with drugs that extend the interval QT, other neuroleptics, especially in the elderly, patients with the syndrome of congenital lengthening interval QT, chronic heart failure, myocardial hypertrophy, hypokalemia, or hypomagnesemia (see "Interactions with Other Drugs").

    Late dyskinesia

    With prolonged use of quetiapine, there is a potential for the development of tardive dyskinesia. If symptoms of tardive dyskinesia occur, it is recommended to lower the dose of the drug or gradually cancel it.

    Severe neutropenia

    In clinical studies of quetiapine, cases of severe neutropenia were infrequent (neutrophil count <0.5 *109/ l). Most cases of severe neutropenia occurred several months after initiation of quetiapine therapy. There was no dose-response effect.Leukopenia and / or neutropenia were resolved after quetiapine treatment was discontinued. A possible risk factor for the onset of neutropenia is a previous decrease in the number of leukocytes and cases of drug-induced neutropenia in the anamnesis. In patients with a neutrophil count <1.0 *109/ l the use of quetiapine should be discontinued. The patient should be observed to identify possible symptoms of infection and control the level of neutrophils (up to a level of 1.5 *109/ l).

    Hyperglycaemia

    Against the background of quetiapine may develop hyperglycemia or exacerbation of diabetes in patients with diabetes mellitus in history. Clinical observation is recommended for patients with diabetes mellitus and patients with risk factors for diabetes mellitus (see section "Side effect").

    Level of lipids

    Against the background of taking quetiapine may increase the concentration of triglycerides and cholesterol (see section "Side effect").

    Elderly patients with dementia

    Quetiapine is not indicated for the treatment of psychoses associated with dementia.

    Some atypical antipsychotics in randomized, placebo-controlled trials increased the risk of developing cerebrovascular complications in patients with dementia. The mechanism of this increase in risk has not been studied.A similar risk of increasing the incidence of cerebrovascular complications can not be ruled out for other antipsychotic drugs or other groups of patients. Quetiapine should be used with caution in patients at risk of stroke.

    Analysis of the use of atypical antipsychotics for the treatment of psychoses associated with dementia in elderly patients revealed an increase in the mortality rate in the group of patients receiving drugs of this group compared with the placebo group. There was no causal relationship between the treatment of quetiapine and the risk of increased mortality in elderly patients with dementia.

    Convulsive seizures

    There were no differences in the incidence of seizures in patients taking quetiapine or placebo. However, as with other antipsychotics, caution should be exercised in the treatment of patients with a history of seizures.

    Malignant neuroleptic syndrome

    Against the background of taking antipsychotic drugs, including quetiapine, can develop malignant neuroleptic syndrome.Clinical manifestations of the syndrome include hyperthermia, altered mental status, muscle rigidity, instability of the autonomic nervous system, an increase in the concentration of creatine phosphokinase. In such cases quetiapine it is necessary to cancel and conduct appropriate treatment.

    Acute reactions associated with drug withdrawal

    With the sharp cancellation of quetiapine, the following acute reactions (withdrawal syndrome) can occur: nausea, vomiting, insomnia, headache, dizziness and irritability. Therefore, it is recommended to cancel the drug gradually for at least one or two weeks.

    Suicide / suicidal thoughts or clinical worsening

    Depression is associated with an increased risk of suicidal thoughts, self-injury and suicide in children, adolescents and young people (under 24). This risk remains until the onset of severe remission. In view of the fact that before the improvement of the patient's condition from the beginning of treatment, several weeks or more may pass, patients should be under close medical supervision before the onset of improvement.According to the generally accepted clinical experience, the risk of suicide may increase in the early stages of the onset of remission.

    Other psychiatric disorders for which therapy is prescribed quetiapineare also associated with an increased risk of suicidal events. In addition, such conditions can be comorbid with a depressive episode. Therefore, the precautions used in the therapy of patients with a depressive episode should be taken in the treatment of patients with other psychiatric disorders. Patients with a history of suicidal events, as well as patients who clearly express suicidal thoughts before starting therapy, are at increased risk of suicidal intentions and suicidal attempts and should be carefully observed during treatment.

    Patients with hepatic insufficiency

    Quetiapine is extensively metabolized in the liver. Therefore, caution should be exercised when using quetiapine in patients with hepatic insufficiency, especially at the onset of therapy.

    Interaction with other medicinal products

    Also see the section "Interaction with other medicinal products".

    The use of quetiapine in combination with strong inducers of the liver enzyme system, such as carbamazepine and phenytoin, helps to reduce the concentration of quetiapine in the plasma and can reduce the effectiveness of quetiapine therapy.

    The administration of quetiapine to patients receiving inductors of the liver enzyme system is possible only if the expected benefit from quetiapine therapy surpasses the risk associated with the abolition of the hepatic enzyme inducer. The change in the dose of inductor preparations of microsomal enzymes should be gradual. If necessary, they can be replaced with drugs that do not induce microsomal enzymes (for example, preparations of valproic acid).

    Taking into account the influence of quetiapine on the central nervous system, quetiapine should be taken with caution in combination with other drugs that have an inhibitory effect on the central nervous system, or alcohol.

    Effect on the ability to drive transp. cf. and fur:Quetiapine can cause drowsiness, so during treatment, patients are not recommended to drive vehicles, and it is not recommended to work with mechanisms that are dangerous
    Form release / dosage:

    Tablets, film-coated, 25 mg, 100 mg, 200 mg.

    Packaging:

    Tablets 25 mg: 30 tablets film-coated in PVC / Al blister. Two blisters together with instructions for use are placed in a cardboard box.

    Tablets of 100 mg and 200 mg: For 15 tablets coated with a film sheath in PVC / Al blister. Four blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:PL-000678
    Date of registration:28.09.2011
    The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia
    Manufacturer: & nbsp
    Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia
    Information update date: & nbsp28.09.2011
    Illustrated instructions
      Instructions
      Up